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Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.

NCT ID: NCT06738654

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-12-31

Brief Summary

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Evaluate the safety and feasibility of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment;

Detailed Description

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Evaluate the safety and feasibility of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment; - Preoperative hospitalization period: Collect patient disease information (including mammography, breast ultrasound, breast enhanced MRI, etc.) - On the day of surgery: Record operating time, intraoperative blood loss, intraoperative complications, intraoperative adverse events, etc.; - Postoperative hospitalization period: Record postoperative complications (postoperative bleeding, necrosis of the flap or nipple-areola complex, subcutaneous emphysema, infection, capsule spasm, postoperative shoulder pain and discomfort, etc.), postoperative pain scores, postoperative pathological biopsy; - Postoperative hospital stay: Calculated from the day of surgery to the day of discharge; - 28 days postoperatively: Understand the complication rate and mortality rate within 28 days postoperatively; - 90 days postoperatively: Understand the complication rate and mortality rate within 90 days postoperatively; - 3-year disease-free survival period (calculated from the time of surgery to the last follow-up or recurrence and metastasis date, recurrence is defined as recurrence in the surgical area and distant metastasis); - 3-year overall survival rate (calculated from the time of surgery to the last follow-up or death).

Conditions

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Invasive Breast Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Experimental Group: Breast-conserving surgery for breast cancer using single-port robotic surgery.

Control Group: Breast-conserving surgery for breast cancer using traditional open surgery.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Breast-conserving surgery for breast cancer using traditional open surgery.

Group Type ACTIVE_COMPARATOR

traditional open surgry

Intervention Type PROCEDURE

Breast-conserving surgery for breast cancer using traditional open surgery.

Experimental Group

Breast-conserving surgery for breast cancer using single-port robotic surgery.

Group Type EXPERIMENTAL

robot-surgery

Intervention Type PROCEDURE

Breast-conserving surgery for breast cancer using single-port robotic surgery.

Interventions

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robot-surgery

Breast-conserving surgery for breast cancer using single-port robotic surgery.

Intervention Type PROCEDURE

traditional open surgry

Breast-conserving surgery for breast cancer using traditional open surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. The patient himself has very high requirements for beauty, and requires no scar on the chest;
2. No chest surgery and radiotherapy.
3. No contraindications to surgery and anesthesia.
4. Clinical I, stage of early breast cancer and the breast has an appropriate volume, can maintain a good breast shape after surgery.
5. Patients in the clinical period who meet the standard of breast conservation surgery after preoperative treatment.
6. Age: 18 and 65 years old.

Exclusion Criteria

1. Inflammatory breast cancer.
2. The tumor is extensive and it's difficult to achieve negative margins or an ideal breast - conserving appearance.
3. Diffusely distributed malignant - characteristic calcifications.
4. The margin is positive after local extensive tumor resection, and a negative margin in pathological examination still can't be ensured after re - resection.
5. The patient refuses.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Xu Yan

OTHER

Sponsor Role lead

Responsible Party

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Xu Yan

Yan Xu,MD., PhD. Department of Breast and Thyroid Surgery Daping Hospital, Army Medical University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Aramy medical center.

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Central Contacts

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yan xu Xu, Doctor

Role: CONTACT

Phone: 023-68729250

Email: [email protected]

Facility Contacts

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Yan Xu

Role: primary

References

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Yu F, Zhang G, Guo L, Luo F, Chen Y, Xu Y. Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial. J Vis Exp. 2025 Aug 19;(222). doi: 10.3791/68459.

Reference Type DERIVED
PMID: 40920680 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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AMCIIT241104

Identifier Type: -

Identifier Source: org_study_id